A company is planning to launch its new List B (Annex II) IVD. What action should the regulatory professional recommend?

When launching a new List B (Annex II) in vitro diagnostic (IVD) device, the most appropriate action is to obtain Notified Body approval of the technical documentation and the quality system. This step is essential because List B devices are subject to a higher level of scrutiny compared to List A devices and typically require a conformity assessment procedure that involves a Notified Body. The Notified Body's evaluation of the quality system and technical documentation ensures that the device meets the necessary safety and performance requirements established by the regulatory framework.

Receiving this approval provides a safeguard for both the manufacturer and the end-users, as it verifies compliance with applicable regulations and standards. This process also provides the regulatory assurance needed for market access within the European Economic Area (EEA).

The other options involve alternatives that do not align with the regulatory requirements for List B devices. Self-certification, batch release, and performance evaluation steps are either not applicable in this context or do not fulfill the requirement for third-party assessment necessary for these types of IVDs. Therefore, obtaining Notified Body approval reflects the rigorous compliance necessary for launching a new List B IVD in the market.